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Ha Cros-Fs Tcblk
EUDAMEDFDA UDIClass I (EU MDR)
Ref 10971953Model RIC
by Wsaud A/S
Identity
- Trade Name
- HA CROS-FS TCBLK EUDAMEDWidex FDA UDI
- Generic Name
- Air-conduction hearing aid, receiver-in-canal FDA UDI
- Device Name
- CROS-FS FDA UDI
- Model / Reference
- RIC EUDAMED10971953 EUDAMEDCROS-FS BTE FDA UDI
- Description
- CROS-FS FDA UDI
Identifiers
- Catalog Number
- 10971953 FDA UDI
- Primary DI / UDI-DI
- 05706069784855 EUDAMEDFDA UDI
- Basic UDI-DI
- 5714880-WSA-62-15-49 EUDAMED
- FDA Product Code
- OSM FDA UDIKLW FDA UDI
- EMDN Code
- Y214599 HEARING AIDS - OTHER EUDAMED
- GMDN Term
- Air-conduction hearing aid, receiver-in-canal FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI874.3400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ha Cros-Fs Tcblk by Wsaud A/S — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5714880-WSA-62-15-49 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wsaud A/S
- EUDAMED SRN
- DK-MF-000015974
Sources (2)
- EUDAMED ef86a12b-b200-4bbe-b034-2821c1b164b1 61 fields · synced Jul 12, 2026
- FDA UDI 498c715b-97fe-43fe-8e9c-7da6cae43b8b 35 fields · synced May 30, 2026